This multicenter, randomized controlled trial aims to evaluate the efficacy and safety of Henagliflozin-Metformin Sustained-Release Tablets (I) versus Metformin Tablets in newly diagnosed type 2 diabetes mellitus (T2DM). A total of 268 participants will be randomized (1:1) into two groups: the experimental group receiving Henagliflozin-Metformin Sustained-Release Tablets (I) (5mg/500mg, once daily) with lifestyle intervention, and the control group receiving Metformin Tablets (500mg, twice daily) with lifestyle intervention. The primary outcome is the change in glycated hemoglobin (HbA1c) from baseline at 24 weeks. Secondary outcomes include changes in fasting/postprandial blood glucose, body weight, metabolic parameters, diabetes remission rate, and safety assessments. This trial will provide evidence for early combination therapy in newly diagnosed T2DM patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
268
henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) (5mg/500mg, once a day, two tablets each time) plus lifestyle intervention
Metformin (500mg, twice a day) plus lifestyle intervention
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGGlycosylated Hemoglobin, Type A1C(HbA1C)
Time frame: 24 weeks
Fasting blood glucose (FBG)
Time frame: 4,12, 24 weeks
2-hour postprandial blood glucose (PBG)
Time frame: 4,12, 24 weeks
Diabetes reversal rate
Time frame: 36 weeks
fasting insulin/C-peptide and postprandial 2-hour insulin/C-peptide
Time frame: 24 weeks
HbA1c
Time frame: 4, 12weeks
Blood lipids (high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], triglycerides [TG])
Time frame: 12, 24 weeks
blood urine acid
Time frame: 12, 24 weeks
Urinary Albumin-to-Creatinine Ratio (UACR)
Time frame: 12, 24 weeks
body weight
Time frame: 4,12, 24 weeks
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